With the rapid advancement of new AI-based therapies in personalized cancer medicine, researchers are calling for a more flexible and safe legal framework to ensure these treatments can reach patients in a timely and secure manner. In a recent research paper published in npj Precision Oncology, experts from Dresden, Leipzig, Marburg, and Paris explored the potential of AI in personalized cancer medicine and highlighted the challenges that come with regulatory approval. They argue that current rigid and slow approval requirements are impeding technological progress and urge for an adaptation of existing regulations.
While the application of AI in precision oncology has primarily focused on the development of new drugs, there is immense potential for AI-based approaches in the planning and implementation of personalized drug and cell therapies. These innovations offer the ability to tailor therapies to individual patients, enhancing efficacy, reducing toxicity, and even personalizing preclinical cell therapies based on molecular properties.
AI-based healthcare is rapidly evolving and has the capacity to support physicians in decision-making, therapy planning, and early multi-cancer precision diagnostics. Additionally, it can facilitate the design of personalized medical products, the development of drug companion apps for patients, and the use of digital twins. Digital twins leverage patient data in real-time to enable more precise diagnosis through simulation and modeling, as well as adapt treatments to individual needs.
However, navigating the regulatory pathways for these AI-based products presents significant challenges. These products involve combining technologies governed by different legal frameworks and regulatory bodies, which are not well addressed in current legislation. The existing approval conditions hinder the speedy clinical application of AI-based personalized medicine. The publication identifies two major challenges: underestimating the importance of emerging technologies in this field and the extent of regulatory change required for more agile approval processes. To address this, fundamental changes are needed.
To accommodate highly personalized treatment approaches, the researchers propose updating risk-benefit assessments. The European Union can adopt solutions already established in the United States for certain categories of low-risk decision support for physicians. Furthermore, the authors suggest allowing for more flexible adaptation of digital tools in the market to ensure safety. Establishing suitable test platforms for on-market monitoring and implementing multi-layered approaches would help distribute the oversight burden and ensure evaluations are more relevant to patient safety.
In conclusion, the integration of AI in personalized cancer medicine holds great promise for improving patient outcomes. To fully leverage its potential, a flexible and safe legal framework is crucial. Adapting regulatory conditions to accommodate these innovations will enable faster access to AI-based therapies and ultimately advance personalized cancer medicine.
1. Source: Coherent Market Insights, Public sources, Desk research
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